A surgical device mitigates over-puncture with a bias spring that biases a leading, cutting edge in the opposite direction of the anticipated over-puncture. An associated locking mechanism is configured to release the force of the bias spring in a direction counter to the direction of insertion when the tension force of tissue against the cutting edge is released. Thus, when an opening in the tissue forms, the tension is released and the cutting edge can move opposite to the direction of insertion of the surgical device at the same time that an applied force drives the instrument in the direction of insertion. In this manner, the spring and locking mechanism cooperate to move the cutting edge opposite to the direction of insertion as soon as an incision is made.
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14. A method comprising:
applying a deployment force to spring load a blade in a deployed position exposed outside a housing with a bias force to return to a retracted position within the housing;
locking the blade with a preload locking force in the deployed position against the bias force;
releasing the deployment force;
pressing the blade against a target surface while in the deployed position, thereby creating a force against the blade; and
converting the force against the blade into a first force to release the preload locking force and a second force normal to an interior surface of the housing to establish a friction fit against the interior surface proportional to the force against the blade.
1. A device comprising:
a housing having an axis;
an instrument slidably retained within the housing and movable along the axis between a first position wherein a functional tip of the instrument extends outside the housing and a second position wherein the functional tip is disposed within the housing;
a biasing mechanism that biases the instrument toward the second position;
a preload lock with one or more features that secure the instrument in the first position against movement by the biasing mechanism; and
a locking mechanism that releases the preload lock and secures the instrument against moving from the first position to the second position by frictionally engaging an interior wall of the housing with a force proportional to a load applied to the functional tip in a direction from the first position to the second position along the axis of the housing.
3. The device of
4. The device of
5. The device of
6. The device of
a mechanical member that converts an axial force on the functional tip to a normal force; and
an interior surface of the housing substantially parallel to the axis and positioned to receive the normal force of the mechanical member, thereby frictionally engaging the functional tip against axial movement due to the axial force.
8. The device of
9. The device of
12. The device of
13. The device of
15. The method of
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In minimally invasive surgical procedures, one or more tissue layers must sometimes be punctured without direct visualization of an instrument tip in order to gain access to a body cavity, duct, or the like. The instruments for such procedures are generally long and slender with high axial stiffness. In use, a surgeon or other user applies sufficient axial force so that the instrument can penetrate into the tissue by cutting, tearing or separating tissue fibers.
At the point of puncture, or the instant when the tissue opens at the tip of the instrument, the force applied to the instrument by tissue tension goes to zero while the force applied by the user remains as a net force accelerating the instrument into the surgical site. Device designers have attempted to improve instruments to mitigate this forward driving force and subsequent acceleration by offering dynamic blade covers, blunt-tipped devices, and other features that indirectly address the problem of over-puncture by seeking to reduce the harmful effects when an over-puncture occurs.
There remains a need for puncture devices that reduce or eliminate the over-puncture event, rather than addressing consequences of an over-puncture after it occurs. There remains a further need for a puncture device that locks in a preloaded state for improved ease of use.
A puncture device mitigates over-puncture with a bias spring that biases a leading, cutting edge in the opposite direction of an anticipated over-puncture. An associated locking mechanism is configured to release the force of the bias spring when a puncture event releases the tension force of a target surface such as tissue against the cutting edge. A preload lock secures the cutting edge in a loaded state until an initial engagement with the target surface. When the cutting edge initially engages tissue with an applied force, the preload lock releases, and when an opening in the tissue forms, the locking mechanism for the cutting edge also releases so that the cutting edge can move opposite to the direction of puncture at the same time that an applied force drives the instrument in the direction of insertion. In this manner, the spring and locking mechanism cooperate to move the cutting edge opposite to the direction of insertion as soon as an incision is made.
The invention may be more fully understood with reference to the accompanying drawings wherein:
All documents mentioned herein are hereby incorporated in their entirety by reference. References to items in the singular should be understood to include items in the plural, and vice versa, unless explicitly stated otherwise or clear from the text. Grammatical conjunctions are intended to express any and all disjunctive and conjunctive combinations of conjoined clauses, sentences, words, and the like, unless otherwise stated or clear from the context. Thus the term “or” should generally be understood to mean “and/or” and so forth.
Disclosed herein are systems and methods for surgical puncture access, and in particular, puncture access using a retraction mechanism that retracts a blade in a direction opposite to a puncture force when a puncture is achieved and the resistive force of intervening tissue is removed. Although the disclosed retraction mechanisms are intended for a trocar in a surgical procedure, the principles of the invention have wide applicability. In a surgical context, any puncture-access device may employ similar techniques to prevent over-puncture, including a Veress needle, a venous access needle for catheter placement, an epidural or spinal tap needle, a cranial drill, and a lung puncture device to correct a collapsed lung.
More generally, the phenomenon of over-puncture appears in areas outside medicine and the principles of the invention may be applied in numerous non-medical contexts. For example, in certain manufacturing processes, a hole is drilled through a wall or vehicle body behind which lies a pipe, electrical conduit, gas tank, or other fragile or dangerous object. A power drill may be adapted to use the principles of the invention in order to drill only through the wall and no further, retracting a drill bit or the like when a complete puncture has been achieved. In similar fashion, a drill press can be adapted to prevent a user from drilling through a part and into a drilling table or chuck. Much larger industrial drilling applications through rock or soil could similarly benefit from these mechanisms to prevent damage due to over-drilling. All such variations that would be apparent to one of ordinary skill in the art are intended to fall within the scope of this disclosure.
The housing 202 may be formed of any suitable material such as biocompatible plastic or surgical stainless steel, and may enclose various components of the device 200. The housing 202 may be a trocar shaped and sized for use in a laparoscopic procedure. More generally, the housing 202 may be of any other shape and size suitable for a particular medical or industrial application as contemplated herein. The housing has an interior 212 that contains various components of the device 200.
The instrument 204 may be slideably retained within the housing so that it can move axially (i.e., along the axis 104 depicted in
The instrument 204 may include a blade 214 such as an off-the-shelf symmetrical scalpel blade or any other blade or cutting instrument, or more generally any functional tip such as a drill bit, an awl or other piercing instrument, or the like. The instrument 204 may also include a shaft 216 that mechanically couples the blade 212 to other components of the device 200. The shaft 216 may be coupled to the blade 214 with a pin, dowel, or any other permanent or removable/replaceable attachment fixture. In
The mechanical control 206 may be coupled (e.g., through the locking mechanism 208) to the instrument 204 and provides a manual control to move the instrument from the second (retracted) position to the first (deployed) position. This may, for example, include a plunger as depicted or any similarly operable device such as a slide or tab on a side of the housing 202 that permits axial movement of the instrument 204 into the deployed position by a user. Thus, the mechanical control 206 may be generally operable at a first end 216 of the housing 202 distal from a second end 218 of the housing where a functional tip of the instrument 204 deploys from the housing 202.
The locking mechanism 208 may be generally configured to secure the instrument against movement toward the second (retracted) position when the instrument is in the first (deployed) position and a force is applied to the blade 214 of the instrument 204 along the axis of the housing 202 and toward the interior 212 of the housing 202, or toward the first end 216 of the housing 202 opposite the second end 216 (the insertion end). The locking mechanism 208 may also release the instrument 204 to move toward the second (retracted) position when the force applied to the blade 214 is removed.
The biasing mechanism 210 generally biases the instrument 204 toward the second position where the instrument 204, or more specifically the blade 214 or other function tip of the instrument is enclosed within the housing 202. The biasing mechanism may, for example, include a coil spring or other spring configuration coupled between the mechanical control 206 (e.g., a plunger) and the housing 202, or any other suitable spring mechanism, elastic mechanism, or the like.
The cooperation of the locking mechanism 208 and the accompanying biasing mechanism 210 is discussed below, and generally facilitates retraction of the instrument 204 in a direction opposite to the direction of puncture when the loading force on the instrument 204 decreases, e.g., after a puncture is achieved.
The first plurality of members 306 may be coupled to a plunger 310 or other mechanical control through a base plate or the like, which may include one or more hinges 312 to permit rotation of the first plurality of members 306 during use. In general, the first plurality of members may be oriented substantially parallel to the interior wall 304 of the housing 302. In this orientation, the plunger 310 can apply a force to move an instrument connected to a shaft 314 from a retracted position inside the housing 302 to a deployed position outside the housing 302. It will be understood that being oriented substantially parallel to the interior wall 304 does not require strict mathematical parallelism. Rather, each of the first plurality of members 306 may be generally closer to parallel than normal, or otherwise oriented sufficiently close to parallel to deliver an axial force from the plunger 310 against a biasing spring or the like to move the shaft 314 forward (or downward, in
The second plurality of members 306 may be hingeably coupled on a first end 316 to the first plurality of members, and coupled to the instrument (e.g., through the shaft 314) on a second end 318. The second plurality of members 306 may be oriented substantially normal to the interior wall 304 of the housing. In this orientation, the first end 316 of each of the second plurality of members 306 can apply a normal force to frictionally engage the interior wall 304 of the housing 302 in a non-sliding mechanical relationship when a load is applied to the blade or other functional tip of an instrument coupled to the shaft 314. More specifically a force applied in a direction from the deployed position to the retracted position along the axis of the housing 302 is converted through the linkages of the locking mechanism into a relatively large normal force into the interior wall 304 at the ends 316 of the second plurality of members 308.
For the second plurality of members 308, being oriented substantially normal to the interior wall 304 does not require strict mathematical orthogonality. Rather, each of the second plurality of members 308 may be generally closer to normal than parallel, or otherwise oriented sufficiently close to normal to deliver a normal force to the interior wall 304 so that the first end 316 of each of the second plurality of members 308 can frictionally engage the interior wall 304 and secure the shaft 314 against further movement toward a retracted position. This arrangement advantageously increases the locking effect of the frictional engagement as the retraction load on the shaft 314 increases.
In operation, the locking mechanism may secure an instrument against moving from a first position outside the housing 302 to a second position within the housing 302 by frictionally engaging the interior wall 304 of the housing 302 with a force proportional to a load applied to the functional tip in a direction from the first position to the second position along the axis of the housing 302. When the load is removed, the complementary normal forces against the interior wall 304 are similarly removed, and the spring or other biasing mechanism can return the instrument to the second (retracted) position.
It will be understood that while two pairs of members are shown, any number of members may be used. For example, the locking mechanism may use three or more pairs of members in a radial configuration within a cylindrical housing interior. Similarly, the principles of the locking mechanism may be usefully adapted to employ a single first and second member in an asymmetrical configuration. Thus, the arrangement of components in the locking mechanism of
The device 500 may include a mechanical stop 504 positioned to prevent collapse of the locking mechanism and comprise of the locking function under large loads. In general, the mechanical stop 504 prevents a lower portion of the integral locking mechanism—that portion that extends substantially normal to the interior wall of the housing—from moving past a normal or ninety degree orientation where further displacement of the shaft will not provide additional frictional force against the interior wall. It will be appreciated that the mechanical stop 504 may be usefully incorporated into any of the embodiments described above. For example, in the embodiment of
Operation of a surgical puncture access device is now described in greater detail with reference to a puncture operation.
As shown in step 1102, the method 1100 may begin with applying a deployment force to spring load a blade in a deployed position exposed outside a housing with a bias to return to a retracted position within the housing. This may for example include depressing a plunger or other control mechanism on the housing of the device. The bias may be achieved for example with a coil spring or any other suitable spring or elastic mechanism, or any combination of the foregoing that can provide sufficient biasing force to retract the blade or other functional tip as contemplated herein.
As shown in step 1104, the method 1100 may include pressing the blade against a target surface while in the deployed position, thereby creating a force against the blade.
As shown in step 1106, the method 1100 may include locking the blade in the deployed position by directing the force against the blade normally against an interior wall of the housing to establish a friction fit proportional to the force. This locking step is performed mechanically by the components of the device in response to the user-controlled steps of spring loading as in step 1102 and engagement with a target surface as in step 1104.
As shown in step 1108, the method may include releasing the deployment force on the plunger or other control mechanism. With the locking obtained in step 1106 and sustained force of the blade against a target surface, the blade can remain locked in the deployed position notwithstanding a driving force (e.g., by the hand of a user) of the housing and blade into the target surface. Thus, the hands of a user are free to manipulate the deployed blade to obtain a puncture of the target surface in any desire manner.
As shown in step 1110, a puncture force may be applied to the housing. This puncture force, which may be any suitable surgical puncture action or technique that maintains a force of the blade against the target surface, may drive the blade through the target surface. As a result, the force against the blade is released and the bias in the spring or other biasing mechanism can withdraw the blade into the retracted position. A similar effect may be achieved by simply removing the blade from the target surface, which would also remove the force against the blade, release the locking mechanism, and cause the spring to retract the blade into the housing. In order to resume the procedure from this state, the blade can once again be deployed with a deployment force as described in step 1102 and the method 1100 may be repeated.
A surgical puncture access tool as described above may in general be improved by a preload lock that secures a blade or other functional tip in a deployed position until ready for use. This may simplify operation of the tool so that the device can be preloaded, e.g., with a plunger or the like, and then pressed against a target surface for application of a puncture force. The axial force from initially pressing the tool against the target surface may first release the preload lock so that the tool is in a state as generally described above for application of a puncture force. Systems and methods for preload locking are now described in greater detail.
As shown in step 1202, the method 1200 may begin with applying a deployment force to spring load a blade in a deployed position exposed outside a housing with a bias to return to a retracted position within the housing. This may for example include depressing a plunger or other control mechanism on the housing of the device to move the blade from a first position within the housing to a second, deployed position extending from the housing. The bias may be achieved for example with a coil spring, flexural spring element, or any other suitable spring, elastic or other compliance mechanism, or any combination of the foregoing that can provide sufficient biasing force to retract the blade or other functional tip as contemplated herein.
As shown in step 1204, the method 1200 may include locking the blade in the deployed position. This may be accomplished, e.g., by any of the preload locking mechanisms described below. In this preloaded state, the blade is deployed in a position protruding from the housing for use in a puncture procedure, and does not require a sustained deployment force to remain in this state. At the same time, the biasing force to return the blade to the retracted position is maintained by the preload lock, which mechanically engages the blade in this deployed, pre-biased position.
As shown in step 1206, the deployment force, e.g., the force applied to a plunger, slider, or the like to deploy the blade, may be released and the device can remain secured in this preloaded state by the preload lock.
As shown in step 1208, the method 1200 may include pressing the blade against a target surface while in the deployed position, thereby creating a force against the blade, e.g., an axial force normal to the target surface and toward the housing.
As shown in step 1210, the method 1200 may include converting the axial force into forces for a number of different functions. In one aspect, the axial force may be converted into a first force to release the preload lock, and the corresponding preload locking force. While this might free the blade to move in response to the biasing force within the device, the axial force may also be converted, e.g., substantially concurrently, into a second force normal to an interior surface of the housing to establish a friction fit against the interior surface proportional to the force against the blade. It will be understood that the second force need not be exclusively normal to the interior surface. Instead, the second force may have any normal component that increases in proportion to the axial loading on the blade such that the blade can be retained in the deployed position under an increasing applied force to achieve a puncture. A variety of mechanisms for providing the first force and second force are described with reference to the figures below.
In general, the second force may be created using mechanisms such as those described above to achieve locking of the blade under sustained force by the blade against the target surface. This locking may maintain the blade in the deployed position notwithstanding a driving force (e.g., by the hand of a user) of the housing and blade into the target surface. Thus, the hands of a user are free to manipulate the deployed blade to obtain a puncture of the target surface in any desire manner, provided that an axial force is maintained on the blade.
As shown in step 1212, a puncture force may be applied to the housing. This puncture force, which may be any suitable puncture action or technique that maintains (and presumably increases) a force of the blade against the target surface, may drive the blade through the target surface.
As shown in step 1214, when a puncture event occurs, the blade may be released from its locked position. That is, when the axial force on the blade decreases due to puncture of the target surface, the corresponding forces that frictionally engage the blade within the housing are concurrently released so that the blade is free to slide within the housing. In this state, the bias in the spring or other biasing mechanism can withdraw the blade into the retracted position. A similar effect may be achieved by simply removing the blade from the target surface, which would also remove the force against the blade, release the locking mechanism, and cause the spring to retract the blade into the housing. In order to resume the procedure from this state, the blade can once again be deployed with a deployment force as described in step 1202 and the method 1200 may be repeated.
It will be appreciated that the normal force created against the interior surface 1502 need not be an exclusively normal force. Rather, as used in this context, “substantially normal” is intended to mean having a sufficiently great normal component to frictionally engaged the instrument in a deployed position with enough tenacity to secure the instrument against axial movement into the housing when a contrary puncture force is applied to the housing in a puncture operation. In general, a range of contact angles for the locking arms of the instrument against the interior surface 1502 may provide sufficient normal force, although a more normal contact angle will in general provide a greater normal contact force, and in practice a substantially normal, or slightly less than normal (as illustrated in
The interior surface may further include a preload lock clearing mechanism 1504. This may for example include a spring loaded or compliance driven latch or hook that secures the engagement feature of the preload lock, e.g., on a cantilevered arm as depicted, laterally away from the corresponding engagement feature of the instrument. When the locking mechanism for the blade applies a normal force, e.g., to the cantilevered arm, this may laterally displace the cantilevered arm until the preload lock is secured by the preload lock clearing mechanism 1504. In this manner, the preload lock is held out of the way of the instrument and a return path for the instrument into the housing, thus removing or reducing any timing requirements for the preload lock relative to the locking mechanism when an axial force is removed.
It will be understood that numerous adaptations may be made for use in rotary tools. For example, while complementary left and right locking mechanisms are depicted, the device may use any number of radially distributed preload locks and locking mechanisms. Further, the device may use a different number of preload locks and locking mechanisms, provided that the resulting configuration permits the preload locks to be released substantially at the same time that the locking mechanism engages. It will also be understood that drills may rotate at hundreds or thousands of revolutions per minute, creating significant centripetal forces on various compliance features such as cantilevered arms or springs. A variety of techniques may be employed to account for such rotationally induced forces so that the device remains locked when axially loaded and becomes released when the axial load is removed. In another aspect, the axial locking mechanism and/or preload lock may be mechanically isolated from the drill-to-drill bit coupling, e.g., with one or more thrust bearings and axial sliders, to permit rotational isolation of the locking mechanisms from the drill.
In one aspect, the instrument 2506 may include one or more notches 2508 or the like to receive one or more corresponding arms 2510 of a plunger 2512. This arrangement may provide certain structural advantages such as permitting the arms 2510 to pivot within the notches 2508, while securely coupling the plunger 2512 to the instrument 2506 against axial displacement.
It will also be noted that where cantilevered arms are used, the cantilevered arms may include one or more relief features such as notches as illustrated to preferentially engage an instrument locking mechanism at one or more locations. This may include functional engagement such as axial locking of the instrument for a puncture operation, or to provide tactile feedback to a user concerning state changes such as initial movement of a plunger or preload locking.
It will be understood that while a flexural compliance mechanism is illustrated, axial compliance sufficient to separate preload lock engagement features may be achieved with a variety of compliance techniques including without limitation any spring, flexural element, resilient material and the like, as well as combinations of the foregoing.
Other techniques may also or instead be used to prevent the preload lock from reengaging when the locking mechanism for a functional tip is released. For example, a viscoelastic damper such as a foam or similar material may couple the cantilevered arms to the interior walls of the housing, or the cantilevered arms may be wholly or partially formed of a viscoelastic material that returns slowly to an unloaded state. In this manner, the cantilevered arms or any similar structure can be fabricated in a manner that will not snap quickly back into an undeformed shape, e.g., where the preload lock engagement features might prevent axial movement of the instrument within the housing.
It will also be noted that the second part 2804 includes arms that rest in corresponding notches of the third part 2806. This permits the arms to rotate as indicated by an arrow 2814 so that when the instrument is deployed and an axial force is applied to the instrument, the arms will tend to laterally displace the cantilevered arms as increasing axial force is applied to provide a locking mechanism as described above.
The method steps of the invention(s) described herein are intended to include any suitable method of causing such method steps to be performed, consistent with the patentability of the following claims, unless a different meaning is expressly provided or otherwise clear from the context. So for example performing the step of X includes any suitable method for causing another party, device, or system, such as a remote user or a remote processing resource (e.g., a server or cloud computer) to perform the step of X. Similarly, performing steps X, Y and Z may include any method of directing or controlling any combination of such other individuals, devices, systems or other resources to perform steps X, Y and Z to obtain the benefit of such steps.
It will be appreciated that the methods and systems described above are set forth by way of example and not of limitation. Numerous variations, additions, omissions, and other modifications will be apparent to one of ordinary skill in the art. While particular embodiments of the present invention have been shown and described, it will be apparent to those skilled in the art that various changes and modifications in form and details may be made without departing from the spirit and scope of the invention as defined by the following claims. The claims that follow are intended to include all such variations and modifications that might fall within their scope, and should be interpreted in the broadest sense allowable by law.
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